Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks (Ulcer)
11 augustus 2026 bijgewerkt door: Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d, MTI University
Optimizing Venous Leg Ulcer Healing Via Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
investigates the comparative effectiveness of two interventions aimed at promoting the healing of venous leg ulcers-a common chronic condition characterized by impaired venous return and poor wound healing in the lower extremities.
The research explores whether structured and supervised calf muscle pump activation exercises, delivered with individualized dose-response protocols, can enhance venous return and improve ulcer healing outcomes more effectively than traditional recommendations for unsupervised home walking.
The structured intervention likely involves targeted exercises designed to optimize the activation and function of the calf muscle pump, which is crucial for facilitating blood flow from the legs back to the heart.
In contrast, the unsupervised home walks represent a less controlled, patient-led approach often prescribed in clinical practice.
By comparing these approaches, the study seeks to determine if a more scientific, structured exercise regimen tailored to each patient's response yields superior healing rates, better compliance, and improved patient quality of life.
Ultimately, the findings may inform best practices for physical therapy and rehabilitation strategies in the management of venous leg ulcers, potentially leading to more personalized and effective treatment protocols in clinical and home settings.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The research aims to determine whether a structured, dose-response regimen of calf muscle pump activation exercises, which are specifically designed and supervised to maximize venous return in the lower limbs, can enhance ulcer healing rates more effectively than the traditional recommendation of unsupervised home walking.
Participants are divided into two groups: one receives guided interventions with tailored exercise frequency, duration, and intensity to systematically activate the calf muscle pump, while the control group is advised to perform regular home walks without supervision or specific guidance.
The study meticulously measures healing outcomes, adherence, vascular function, and patient quality of life to assess the true impact of structured exercise versus informal activity.
By analyzing these variables, the research seeks to provide evidence-based recommendations for optimizing therapeutic strategies in the management of venous leg ulcers, potentially shifting clinical practice toward more prescriptive and individualized physical activity guidelines, and highlighting the importance of targeted exercise science in post-secondary physical education and rehabilitation curricula.
Studietype
Ingrijpend
Inschrijving (Geschat)
80
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria
- Age (ge 20 - 60) years with a confirmed, non-healing VLU (present for \(>6\) weeks).
- Ulcer surface area between \(2 \text{ cm}^2\) and \(20 \text{ cm}^2\).
- Ankle-Brachial Index (ABI) \(\ge 0.8\), ensuring adequate arterial perfusion.
- Able to provide informed consent and comply with follow-up appointments. Exclusion Criteria
- Severe, uncompensated congestive heart failure (NYHA Class III or IV).
- Active local wound infection or systemic osteomyelitis.
- Deep vein thrombosis (DVT) diagnosed within the past 3 months.
- Severe osteoarthritic limitations rendering ankle movement impossible.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Group A: Dose-Response Structured CMP Activation Strategy
Weeks 1-4 (Activation Phase): Focuses on establishing baseline mobility. Weeks 5-8 (Hypertrophy & Ejection Phase): Focuses on building muscle pump volume. Weeks 9-12 (Power & Hemodynamic Clearance Phase): Focuses on clearing pooled blood under high pressure. |
Progression Protocol (The Dose-Response) Weeks 1-4 (Activation Phase): Focuses on establishing baseline mobility. Ankle ROM Drills: 3 sets of 15 repetitions of passive and active dorsiflexion/plantar flexion stretches utilizing an inelastic stretching strap. Goal: Overcome joint stiffness to reach >10° of passive dorsiflexion. Seated CMP Loading: Seated heel raises with resistive elastic bands (15 repetitions, 4 sets). Weeks 5-8 (Hypertrophy & Ejection Phase): Focuses on building muscle pump volume. Standing Closed-Kinetic Chain Exercises: Standing bodyweight heel raises performed on a step to allow a deep negative heel deficit (eccentric loading). 4 sets of 12 repetitions. Incline Ergometry: 15 minutes of continuous stationary cycling or treadmill walking at a 5% to 8% incline to force a natural heel-strike and powerful toe-off phase. Weeks 9-12 (Power & Hemodynamic Clearance Phase): Focuses on clearing pooled blood under high pressure. Resisted Plantarflexion: Single-leg standing hee |
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Actieve vergelijker: Group B: Unsupervised Home Walking (Active Control)
Completely independent and self-managed home program
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Patients were issued a medical-grade wrist-worn pedometer and a matching ankle sensor.
The device display was blinded (blacked out) to prevent active self-biasing or behavioral modification based on step count numbers.
Data was downloaded retroactively by researchers at bi-weekly clinic visits to measure real-world gait speeds, step counts, total active time, and spatial asymmetries without the patient altering their natural routine.
No constraints were placed on gait modifications.
If the patient guards their wound by walking flat-footed or shuffling, the behavior is recorded but not corrected, providing a true representation of unguided real-world walking mechanics.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
wound healing volume (cm3))
Tijdsspanne: at base line and 12 weeks
|
saline injection
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at base line and 12 weeks
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wound healing (surface area(cm2)
Tijdsspanne: at base line and 12 weeks
|
using Image J software
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at base line and 12 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Venous Filling Index (VFI) (mL/sec)
Tijdsspanne: at baseline and 12 weeks
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The Venous Filling Index (VFI) is a quantitative measurement used to assess the severity of venous reflux in patients with venous leg ulcers.
It is determined using air plethysmography, which tracks changes in leg volume during and after a series of standardized calf muscle contractions.
VFI is calculated as the rate at which blood refills the veins after each contraction, expressed in milliliters per second (mL/sec).
A higher VFI indicates more rapid venous refilling, reflecting greater venous insufficiency and reflux.
Monitoring VFI allows clinicians to objectively compare the effectiveness of interventions, such as structured calf muscle pump activation strategies versus unsupervised home walks, in improving venous return and supporting ulcer healing.
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at baseline and 12 weeks
|
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Ejection Fraction (EF) (%).
Tijdsspanne: at base line and 12 weeks
|
To measure Ejection Fraction (EF) as an indicator of calf muscle pump efficacy during a single contraction, use duplex ultrasound or air plethysmography to assess venous volume changes in the lower leg.
First, record the baseline venous volume with the patient in a relaxed, supine position.
Then, instruct the patient to perform a single, deliberate calf muscle contraction (such as plantarflexion).
Immediately measure the post-contraction venous volume.
EF is calculated as the percentage of blood ejected from the veins during the contraction: EF (%) = [(baseline volume - post-contraction volume) / baseline volume] × 100.
This value quantifies how effectively the calf muscle pump expels venous blood with each contraction.
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at base line and 12 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 oktober 2026
Primaire voltooiing (Geschat)
1 februari 2027
Studie voltooiing (Geschat)
5 februari 2027
Studieregistratiedata
Eerst ingediend
4 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
11 augustus 2026
Eerst geplaatst (Werkelijk)
13 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
11 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB00014233-94
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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